New Drug Approvals Archive - April 2019

April 2019

Asceniv (immune globulin intravenous, human – slra) Injection

Date of Approval: April 1, 2019
Company: ADMA Biologics, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Asceniv (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI).

FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency
Asceniv (immune globulin intravenous, human – slra) FDA Approval History

Dovato (dolutegravir and lamivudine) Tablets

Date of Approval: April 8, 2019
Company: ViiV Healthcare
Treatment for: HIV Infection

Dovato (dolutegravir and lamivudine) is a once-daily, single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) indicated for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine.

Evenity (romosozumab-aqqg) Injection

Date of Approval: April 9, 2019
Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Balversa (erdafitinib) Tablets

Date of Approval: April 12, 2019
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Balversa (erdafitinib) is a once-daily, oral, pan-fibroblast growth factor receptor for the treatment of patients with locally advanced or metastatic urothelial cancer.

Plenity (cellulose and citric acid) Capsules

Date of Approval: April 12, 2019
Company: Gelesis
Treatment for: Obesity

Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in adults who are overweight or obese. It works by inducing a feeling of fullness so that patients eat less and lose weight.

Skyrizi (risankizumab-rzaa) Injection

Date of Approval: April 23, 2019
Company: AbbVie Inc.
Treatment for: Plaque Psoriasis

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis.

Duobrii (halobetasol propionate and tazarotene) Lotion

Date of Approval: April 25, 2019
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination indicated for the topical treatment of plaque psoriasis.

Eticovo (etanercept-ykro) Injection

Date of Approval: April 25, 2019
Company: Samsung Bioepis Co., Ltd.

Eticovo (etanercept-ykro) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.